肉毒桿菌改善膀胱過動症患者之自發性逼尿肌過度活動


  May 21, 2007 — 根據六月號《泌尿醫學期刊》發表的隨機、雙盲、對照研究,A型肉毒桿菌(Botulinum toxin type A),即一般人所知的肉毒桿菌(Botox),能改善有膀胱過動症(overactive bladder,以下簡稱 OAB)患者的特發性逼尿肌過度活動(idiopathic detrusor overactivity,以下簡稱 IDO),治療好處包括改善生活品質,且效果至少能維持24週。
  
  首席研究員Arun Sahai於新聞稿中表示,本項研究的發現很重要,因為若OAB患者對當前療法的反應不甚滿意,且也不考慮接受侵入性手術,那就得需要有新的療法,以滿足其需求;研究提出肉毒桿菌對有OAB症狀的患者而言,或許會是個極有希望的治療選項。Sahai為英國倫敦Guy’s醫院研究員。
  
  於該研究中,34名難治型OAB及IDO確診的患者,被隨機分配接受200 U的肉毒桿菌(n = 16) 或是安慰劑(n = 18) 的逼尿肌肉注射;之前,這34名參與者在為期六週或更長的抗副交感神經藥物療法的試驗中未達到預期效果,乃因藥效不佳或耐受性不佳。
  
  倫敦King’s學院的研究報告共同執筆者Prokar Dasgupta指出,本研究顯示,此療法對先前治療無效的患者具實際的好處,這些患者深受其OAB症狀所困擾;試驗初期,肉毒桿菌組中有81%和安慰劑組中有67%的患者,每天都有著急迫性尿失禁的狀況發生。
  
  主要結果是觀察正常膀胱最大容積(maximum cystometric capacity),而次要結果是觀察灌注膀胱收縮圖及反射逼尿肌量期間,包括膀胱過動症狀、膀胱餘尿、逼尿肌壓最大值等的改變。
  
  以簡式尿失禁影響問卷及簡式泌尿生殖系統疾病量表來衡量生活品質;於注射後第4及12週,研究尚未混合時,進行後續的評估,並於第24週對肉毒桿菌組做進一步的追蹤。
  
  相較於安慰劑組,在接受肉毒桿菌治療的患者中,於第4週(差異,144.69 mL;95%信賴區間[CI],100.95至215.75;P < .0001)及於第12週(差異,95.71 mL;95%信賴區間[CI],47.47至172.45;P = .001,P = .003)觀察到正常膀胱最大容積有明顯的增加;肉毒桿菌會減少急迫性尿失禁的次數(P < .001, P = .003),於第4和12週時,急迫性尿失禁的次數較為減少(分別為P = .03,P = .008);在肉毒桿菌組中,急迫性尿失禁的次數於第4週就減少了(P = .005)。
  
  整體而言,以肉毒桿菌進行的治療,耐受性佳且無重大的併發症;膀胱餘尿於第4週時增加(P = .024),但在第12週時就減少(P = .406)。
  
  在膀胱餘尿增加的患者中,6名需要接受乾淨間歇性自行導尿(clean intermittent self catheterization,以下縮寫為CISC),並有著症狀型泌尿道感染。
  
  注射肉毒桿菌在生活品質上帶來了明顯的改善,而延伸試驗指出,效果能維持至少24週;研究執筆者總結表示,對IDO病例的泌尿動力輔助測量及生活品質等面向觀察,200 U的肉毒桿菌似乎能改善症狀;提供病患詳盡的諮詢是必要的,特別是在考量可能需要進行CISC時。
  
  美國食品暨藥物管制局目前尚未核准肉毒桿菌用於治療任何類型的OAB,在歐洲的相關管制部門亦未核可。
  
  此研究由Allergan公司及英國泌尿醫學基金會所贊助。

Botox May Improve Idiopathic D

By
Medscape Medical News

May 21, 2007 — Botulinum toxin type A (Botox) can improve idiopathic detrusor overactivity (IDO) in patients with symptoms of overactive bladder (OAB), according to the results of a randomized, double-blind, placebo-controlled study reported in the June issue of the Journal of Urology. Treatment benefits, including improved quality of life, were maintained for at least 24 weeks.

“The findings of this study are important because there is a need for new treatments for OAB patients who have unsatisfactory responses to therapies which are currently available and who do not want to consider invasive surgery,” principal investigator Arun Sahai, a research fellow at Guy’s Hospital, London, United Kingdom, says in a news release. “This study demonstrated that botulinum toxin type A may be a promising treatment option for patients with OAB symptoms.”

In this study, 34 patients with treatment-refractory OAB and confirmed IDO were randomized to intradetrusor injections of 200 U botulinum toxin A (n = 16) or placebo (n = 18). Participants had failed on a trial of anticholinergic therapy for 6 weeks or more because of poor efficacy or poor tolerability.

“This study showed that this treatment had real benefits for patients for whom previous treatments had not worked,” says coauthor Prokar Dasgupta, from King’s College, London. “These were patients who were seriously affected by their OAB symptoms. At baseline, 81% of patients in the botulinum toxin type A treatment group and 67% in the placebo treatment group were experiencing urge urinary incontinence daily.”

The main endpoint was change in maximum cystometric capacity, and secondary endpoints included changes in overactive bladder symptoms, postvoid residual, maximum detrusor pressure during filling cystometry, and reflex detrusor volume.

The Incontinence Impact Questionnaire short form and Urogenital Distress Inventory short form were used to measure quality of life. Follow-up evaluations were at 4 and 12 weeks after injection, when the study was unblended, with further follow-up in the botulinum toxin type A group at 24 weeks.

In patients treated with botulinum toxin type A, there were significant increases, compared with placebo, in maximum cystometric capacity at 4 weeks (difference, 144.69 mL; 95% confidence interval [CI], 100.95 to 215.75; P < .0001) and 12 weeks (difference, 95.71 mL; 95% CI, 47.47 to 172.45; P = .001). Botulinum toxin type A was associated with reduced frequency (P < .001, P = .003) and fewer episodes of urgency urinary incontinence (P = .03, P = .008) at 4 and 12 weeks, respectively. In the botulinum toxin type A group, urgency was reduced at 4 weeks (P = .005)

Overall, treatment with botulinum toxin type A was well tolerated without major complications. Postvoid residual increased at 4 weeks (P = .024) but became insignificant by 12 weeks (P = .406). Of the patients with increased postvoid residual, 6 required clean intermittent self-catheterization (CISC) and developed symptomatic urinary tract infection.

Botulinum toxin type A injection was associated with significant improvements in quality of life, and the extension study suggests that benefits were maintained for at least 24 weeks. Botulinum toxin type A “at 200 U appears to improve symptoms, urodynamic parameters, and [quality of life] in cases of IDO,” the authors conclude. “Careful patient counseling is necessary, especially concerning the possible need for CISC.”

Botulinum toxin type A is not currently approved by the US Food and Drug Administration for the treatment of any form of OAB, nor is it approved for this use by regulatory agencies in Europe.

Allergan, Inc and the British Urological Foundation funded this research.

J Urol. 2007;177:2231-2236.

    
相關報導
肉毒桿菌對於膀胱過動症的神經調節效果可能最好
2016/10/21 上午 10:08:58
尿道中段吊帶對於壓力型尿失禁有幫助
2015/7/15 上午 09:32:55
合併治療可改善膀胱控制
2015/6/12 上午 10:41:51

上一頁
   1   2   3   4   5   6   7   8   9   10  




回上一頁